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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROTECTA XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS353
Date Received05/14/2012
Decision Date06/13/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALIGN HEADER MANUFACTURING PROCESSES OF THE PROTECTA XT VR (D314VRM), PROTECTA VR (D334VRM), SECURA VR (D204VRM) AND MAXMIO II VR (D264VRM) DF4 ICDS WITH CURRENTLY MANUFACTURED DEVICES.
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